Injection Needles Recalled for Inadequate Manual Cleaning Process
Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device presenting a risk-of-harm scenario where inadequate cleaning of surgical injection needles could result in patient infection. No illnesses or injuries have been reported, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling 1,127 Injection Needle, LUER-lock, 0.8mm (REF: 26175PD) units distributed across the United States, Mexico, Canada, and Germany.
The company determined that the manual cleaning process for these needles cannot be adequately assured. These needles are intended for use in general and visceral surgery.
If used, the affected needles may expose patients to a higher risk of infection due to the inability to ensure adequate cleaning. All lot numbers of the recalled product are included.
The recalled product
- Product
- Injection Needle, LUER-lock,0.8mm, REF: 26175PD
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 1,127
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04048551099391. All lot numbers.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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